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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06620237




Registration number
NCT06620237
Ethics application status
Date submitted
8/02/2023
Date registered
1/10/2024
Date last updated
29/10/2024

Titles & IDs
Public title
BIO|MASTER.CSP Study
Scientific title
Pivotal Study of the Amvia Pacemaker and Solia CSP S Pacing Lead on Conduction System Pacing
Secondary ID [1] 0 0
BA113
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Pacing, Artificial 0 0
Cardiac Pacemaker, Artificial 0 0
Cardiac Resynchronization Therapy Devices 0 0
Bradycardia 0 0
Conduction Disorder 0 0
Conduction Defect, Cardiac 0 0
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Normal development and function of the cardiovascular system
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Implantation of the Solia CSP S pacing lead for LBBAP

No intervention: LBBAP Amvia - All patients with successful implantation of Amvia pacemaker and a lead in a position intended for LBBA pacing.

Experimental: LBBAP Solia CSP S - All patients with successful implantation of a Solia CSP S lead in LBB area. Additionally, all patients with a non-successful Solia CSP S implantation attempt in which an ADE (adverse device effect) or SADE (serious adverse device effect) related to the Solia CSP S lead occurred.


Treatment: Devices: Implantation of the Solia CSP S pacing lead for LBBAP
Left bundle branch area pacing using a Solia CSP S lead
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Amvia related SADE-d free rate
Timepoint [1] 0 0
6 months (183 days) after implantation
Primary outcome [2] 0 0
Solia CSP S related SADE-d free rate
Timepoint [2] 0 0
6 months (183 days) after implantation
Secondary outcome [1] 0 0
Amvia related SADE-d free rate
Timepoint [1] 0 0
12 months (365 days) after implantation
Secondary outcome [2] 0 0
Solia CSP S related SADE-d free rate
Timepoint [2] 0 0
12 months (365 days) after implantation
Secondary outcome [3] 0 0
Rate of successful acute CSP implantation of Solia CSP S
Timepoint [3] 0 0
At the day of implantation
Secondary outcome [4] 0 0
Sensing performance
Timepoint [4] 0 0
At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
Secondary outcome [5] 0 0
Pacing performance
Timepoint [5] 0 0
At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
Secondary outcome [6] 0 0
Physiologic ventricular excitation
Timepoint [6] 0 0
At the day of implantation and at the date of each in-office patient follow-up visit (1-, 6-, 12-month follow-up, and annual follow-up*) * please refer to study duration in study description section
Secondary outcome [7] 0 0
Mid-term change in LVEF
Timepoint [7] 0 0
At baseline, at the 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
Secondary outcome [8] 0 0
Mid-term change in LVESV
Timepoint [8] 0 0
At baseline, at the 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
Secondary outcome [9] 0 0
Mid-term change in quality of life, EQ-5D-5L (EuroQol) questionnaire
Timepoint [9] 0 0
At baseline after patient enrollment prior to implantation, at the date of 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section
Secondary outcome [10] 0 0
Mid-term change in quality of life, SF-36 (Short Form Health Survey) questionnaire
Timepoint [10] 0 0
At baseline after patient enrollment prior to implantation, at the date of 6-month follow-up, at the 12-month follow-up and at all following annual in-office follow-ups*, if applicable; * please refer to study duration in study description section

Eligibility
Key inclusion criteria
For patient enrollment in the study all of the following inclusion criteria have to be fulfilled at the time of enrollment:

* Standard indication for de novo pacemaker implantation or cardiac resynchronization therapy (CRT)
* Patient is intended for implantation of a pacemaker or CRT-P system with left bundle branch area stimulation
* Ability to understand the nature of the study
* Ability and willingness to perform all follow-up visits at the study site
* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Enrollment of a patient is not permitted if at least one of the following criteria is fulfilled:

* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
* Expected to receive heart transplantation or ventricular assist device within 12 months
* Life-expectancy less than 12 months
* Pregnant or breast feeding
* Age less than 18 years
* Participation in another interventional clinical investigation (according to the definition given in the CIP)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biotronik SE & Co. KG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The goal of this clinical study is to test the clinical safety and performance of the Amvia pacemakers and the Solia CSP S lead when used for left bundle branch area pacing (LBBAP). The patient population consist of patients with cardiac pacemaker indication or cardiac resynchronization therapy indication and intended for implantation of a system with left bundle branch area stimulation. Participants will visit sites at enrollment in the study, at implantation and pre-hospital discharge, 1-, 6- and 12-month follow-up visits. Additional annual follow-up(s) may apply until study termination after regulatory approval of Solia CSP S. The total duration of the clinical investigation is expected to be until September 2027, with last patient out (LPO). During the visits the regular pacemaker and lead measurement are performed. A 12-lead ECG is recorded to document intrinsic and ventricularly paced heart rhythm to assess left bundle branch area pacing. Programming of the pacemakers will be done according to the participant´s therapeutical needs.

The study will be conducted in approximately 18 sites in Europe, Australia and New Zealand where more than one physician per site are expected to participate.
Trial website
https://clinicaltrials.gov/study/NCT06620237
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jan De Pooter, MD, PhD
Address 0 0
University Hospital Ghent, Gent (Belgium)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mathias Freudigmann
Address 0 0
Country 0 0
Phone 0 0
+49 30 68905
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06620237